FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
LEVO C3
K Number: K083017
·
Decision Oct 24, 2008
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- LEVO C3
- K Number
- K083017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Levo AG
- Date Received
- October 9, 2008
- Decision Date
- October 24, 2008
- Product Code
- IPL
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IPL | Wheelchair, Standup | FDA class 2 | Physical Medicine |
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